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RecruitingNot applicableNCT02984761
Official study title

Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy

Study summary

Patients with stage I non-small cell lung cancer have been historically treated with surgery whenever they are fit for an operation. However, an alternative treatment known as stereotactic radiotherapy now appears to offer an equally effective alternative. Doctors believe both are good treatments and are therefore conducting this study to determine if one may be possibly better than the other.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedStereotactic Radiotherapy and Anatomic Pulmonary Resection

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 23, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Not applicable

Interventional

Where is it offered?17 U.S. locations

Locations may change over time.

Who runs it?VA Office of Research and Development

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
VA Office of Research and Development
Interventions being studied
Radiation: Stereotactic Radiotherapy; Procedure: Anatomic Pulmonary Resection
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Early-stage or resectable→
Treatment approach
Radiation therapy→Surgery→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Inclusion Criteria for Screening
  • Any patient with a preliminary diagnosis of stage I Non-Small Cell Lung Cancer (NSCLC), whether pathologically proven by biopsy, or highly suspicious by radiographic imaging. \[Participants will ultimately need biopsy confirmation before enrolling\]
  • Primary tumor size less than or equal to 5 cm by CT (may include CT images from PET/CT)
  • Karnofsky performance status greater than or equal to 70
  • Participant has willingness and ability to provided informed consent for participation Inclusion Criteria for Randomization
  • Biopsy proven non-small cell lung cancer
  • Participant's case reviewed at multidisciplinary conference
  • Tumor size less than or equal to 5cm (measured on the most recent CT images available, and may include PET/CT images)
  • Tumor is equal to or greater than 1.0cm from the trachea, esophagus, brachial plexus, 1st bifurcation of the proximal bronchial tree, or spinal cord (measured on the most recent CT images available, and may include PET/CT images).
  • Mandatory FDG-PET/CT within 60 days of the randomization date (note: FDG-PET/CT may need to be repeated prior to treatment if outside of this requirement)
  • Mandatory pathological assessment of any lymph nodes \>10mm with a SUV \>2.5 seen on FDG- PET/CT
  • Mandatory biopsy of any additional concerning lesions seen on FDG-PET/CT, to make better determination that the patient is not harboring metastatic disease or a secondary primary malignancy.
  • Pre-operative FEV1 greater than or equal to 40% of predicted value and pre-operative DLCO greater than or equal to 40% of predicted value.
  • Formally evaluated and documented by a local thoracic surgeon to be medically fit to undergo a complete anatomic pulmonary resection (wedge resection not allowed)
  • Formally evaluated and documented by a local radiation oncologist to be eligible to receive protocol-defined stereotactic radiotherapy
  • Participant willingness to be randomized

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • VA Long Beach Healthcare System, Long Beach, CALong Beach, California
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los Angeles, California
  • Bay Pines VA Healthcare System, Pay Pines, FLBay Pines, Florida
  • Miami VA Healthcare System, Miami, FLMiami, Florida
  • Edward Hines Jr. VA Hospital, Hines, ILHines, Illinois
  • Richard L. Roudebush VA Medical Center, Indianapolis, INIndianapolis, Indiana
  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MDBaltimore, Maryland
  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MABoston, Massachusetts
  • VA Ann Arbor Healthcare System, Ann Arbor, MIAnn Arbor, Michigan
  • Minneapolis VA Health Care System, Minneapolis, MNMinneapolis, Minnesota
  • Durham VA Medical Center, Durham, NCDurham, North Carolina
  • Louis Stokes VA Medical Center, Cleveland, OHCleveland, Ohio

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 23, 2026. Always confirm current availability with the study team.

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